Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer
Inclusion Criteria:
1. 18 years of age or older.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
3. Childs class of A or B (up to 9).
4. Hepatocellular carcinoma (HCC) is unresectable with liver-predominant disease or
subject has HCC and refused surgery or subject is diagnosed hepatic metastases from
any solid tumor. (Multifocal HCC is acceptable, no diffuse HCC).
5. Subject is voluntarily participating in the study and has signed the informed
consent.
Exclusion Criteria:
1. Contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or
specific mixture of chemotherapy drugs to be used).
2. Evidence of severe or uncontrolled systemic diseases.
3. Congestive cardiac failure >NYHA class 2 MI within 6 months, active coronary artery
disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta
blockers or digoxin, unstable angina, or laboratory finding that in the view of the
investigator makes it undesirable for the patient to participate in the trial.
4. Known allergy to Lipiodol (Ethiodol), poppy seed oil, or iodinated contrast agents
(that cannot be adequately mitigated with pre-procedure medication).
5. Main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis
is acceptable.
6. Subject is breastfeeding.
7. Subject is pregnant